Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Time to Union
研究概览
简要总结
To assess if vitamin D status in the elective foot and ankle fusion population affects fusion healing categorically (fused vs. un-fused).
详细描述
This study will be a randomized, 1:1 placebo controlled, blinded, prospective study of level I evidence. The investigators will recruit patients undergoing a major ankle, hindfoot, or midfoot arthrodesis and obtain serum vitamin D levels. Patients that are vitamin D deficient (<30 ng/mL) will then be randomized into two treatment groups: vitamin D supplementation (50,000 IU D2) and no vitamin D supplementation, receiving placebo. Vitamin D levels will be drawn on the day of surgery and 6-8 weeks post-operatively. Outcome variables tested in this study are as follows: bone fusion as an event, time to bone fusion, VAS, and SF-36.
The study will be conducted at 4 investigative sites within the Allegheny Health Network; West Penn Hospital, Forbes Regional Hospital, Twin Towers and Steel Valley Orthopedics & Sports Medicine, Jefferson Hills, PA. Recruitment will stop when approximately 150 subjects are entering the follow-up phase of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The patients will be blinded for the duration of the study. This will be accomplished by providing the patients with over encapsulated vitamin D and placebo in pill bottles. Twelve (12) over encapsulated 50,000 IU vitamin D2 or placebo tablets will be packaged in pill bottles for patient use. The Foot & Ankle Institute CRC will document which drug the patients received.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age 18 to 89 years undergoing ankle, hindfoot, or midfoot arthrodesis surgery
- •Vitamin D serum level <30 ng/mL including those concurrently taking vitamin D
- •Women 18 years of age must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
排除标准
- •Revision surgery
- •Tobacco use which has been shown to affect bone healing and increase risk of nonunion
- •Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease (EXAMPLE below):
- •AST/SGOT > 2.0 times the upper limit of normal ALT/SGPT > 2.0 times the upper limit of normal Total bilirubin > 2.0 times the upper limit of normal Hemoglobin < 9 gm/dL White blood cell count < 3,000/ mm3 Platelet count < 100,000/mm3 Creatinine > 2.0 times the upper limit of normal
- •Preexisting disorders known to adversely affect bone healing (e.g. diabetes mellitus with HbA1C greater than or equal to 7, peripheral vascular disease, certain connective tissue disorders, and congenital or acquired disorders of bone metabolism)
- •Preexisting disorders affecting Vitamin D metabolism and/or calcium phosphate homeostasis (e.g. renal failure, hepatic failure, congenital defects in vitamin D metabolism, parathyroid disorders, conditions causing abnormal calcium and/or phosphate absorption)
- •Open wounds to lower extremities which has been shown to increase risk of infection and nonunion
- •Any investigational drug use within 30 days prior to enrollment.
- •Participation in ongoing clinical research
- •Pregnant or lactating females.
- •Patients who are unable to swallow due to acuity of illness or physiologic reason
- •Patients who are unable to provide consent for the study including inability to read or speak English
- •Prisoners who are patients because of their vulnerable population and inability to follow-up
- •Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
研究组 & 干预措施
Vitamin D
12 over encapsulated 50,000 IU Vitamin D2
干预措施: Vitamin D2 (Drug)
Placebo
12 over encapsulated placebo tablets
干预措施: Placebo (Other)
结局指标
主要结局
Time to Union
时间窗: 9 months
Arthrodesis Union using radiographic union determined by independent reviewers
次要结局
- Patient Reported Outcomes SF-36 Questionnaire(9 months)
- Patient Reported Outcomes VAS Survey Scores(9 months)
研究者
Alan Catanzariti
Program Director, Foot and Ankle Residency Training Program
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)